Dr Joachim Ermer, Ermer Quality Consulting, Germany
Besides regulatory expectations, these Live Online Training Courses provide practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. A rational and efficient validation approach is ultimately based on the respective routine application, which should be reflected in the validation design. This includes the identification of the relevant performance parameters, the selection of appropriate tests and calculations and, in particular, the establishment of acceptance criteria for the evaluation.
Both trainings focus on the relevant performance characteristics, taking the - long-awaited - revision of the ICH Q2 guideline as well as the new Q14 guideline Analytical Procedure development into consideration. Lifecycle aspects will be included in the discussion.
According to EU GMP Guide Part 1, Chapter 6, Quality Control (6.15) and US 21 CFR 211.194, analytical procedures must be suitable for their intended purpose. The regulatory requirements to validation of analytical procedures utilised for release and stability studies of drug substances and drug products are described in the ICH guideline Q2(R1). However, its degree of detail is rather low, and the discussion is mainly focused on chromatographic methods. A broader consideration of other analytical techniques as well as alignment with lifecycle aspects is intended with the revision of Q2. The latter is also in the focus of the new ICH Guideline Q14 Analytical Procedure Development and is already content of the USP General Information Chapter <1220> The Analytical Procedure Lifecycle.
These Live Online Training Courses are aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements for validation of analytical procedures, are interested to participate in a discussion of the revised ICH guideline Q2, and who are interested in practical recommendations for an efficient design, execution, and evaluation of a successful analytical validation.
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Lifecycle Concept, ICH Q2 Revision and Q14
- The Analytical Procedure Lifecycle – USP General Information Chapter <1220> and ICH Q14
- Overview on important adjustments and complementations in ICH Q2(R2)
- Reportable range
Analytical Target Profile
- Requirements to the analytical performance
- Error types
- ATP in Q2(R2) and Q14
- Evaluation of performance parameters (simple, statistical)
- Aspects of an efficient validation
- Precision levels (system precision, repeatability, intermediate precision, reproducibility)
- Precision in ICH Q2(R2)
- Acceptance limits for Assay
- Derivation from probability, measurement uncertainty, tolerance factors
- Design of precision studies and calculations
- Uncertainty of precisions: point estimators and confidence intervals
- Optimisation of precision by averaging (replication strategy)
- Precision of the reportable value (small molecules, bioassay)
- Assay for small molecules, bioassay
- ICH Q2(R2): Comparison, recovery, and technology-inherent justification, combined evaluation of accuracy and precision
- Statistical significance and equivalence tests
- Variability and expected difference between means
- Acceptance criteria for assay
Workshop: Multiple Choice-Questions (from Publications)
- How to avoid mistakes in Validation